Product Safety Standards--Recordkeeping and Third Party Disclosure Requirements

Forms and Documents

Document Name	Status
Produce Safety Standards ss 1-25-13.doc Supporting Statement A	2013-01-25

IC Document Collections

IC ID	Document Title	Status
205608	Posting signage	New
205607	Documentation (one-time burden third party disclosure)	New
205606	Recordkeeping Related to Sprouts--Documentation of Treatment	New
205605	Review of Records	New
205604	Recordkeeping Related to Corrective Actions	New
205603	Recordkeeping Related to Sprouts--Testing for E.coli and Salmonella/Listeria	New
205602	Recordkeeping Related to Sprouts--Sampling Plan	New
205601	Recordkeeping Related to Sprouts--Environmental Monitoring Plan	New
205600	Teating Requirements for Sprouts--Testing for Listeria	New
205599	Testing Requirements for Sprouts--Testing for E.coli and Salmonella	New
205598	Recordkeeping Related to Cleaning and Sanitation--Cleaning worker tools/machinery	New
205597	Recordkeeping Related to Soil Amendments	New
205596	Documentation of Certificates of Compliance	New
205595	Recordkeeping Related to Water--Documentation to Support Alternative to Requirements of 112.44(c)	New
205594	Recordkeeping Related to Agricultural Water--Testing for E.coli when water is directly applicated/for handwashing/e.coli in other water uses	New
205593	Recordkeeping Related to Agricultural Water--Documentation of Monitoring Water Treatment	New
205592	Recordkeeping Related to Agricultural Water--Records of Analytical Test Results	New
205591	Recordkeeping Related to Agricultural Water--Findings of Water System Inspection	New
205590	Testing Requirements for Agricultural Water--Testing for E.coli when water is directly applicated/Analytical Testing	New
205589	Testing Requirements for Agriculture Water--Testing Water Used for Hand Washing	New
205588	Testing Requirements for Agricultural Water--E.coli Testing	New
205587	Training	New
205586	Variances (one-time burden)	New
205585	Sprouts--Establishment of Sampling Plan (one-time burden)	New
205584	Sprouts--Establishment of Environmental Monitoring Plan (one-time burden)	New
205583	Recordkeeping Related to Soil Amendments (one-time burden)	New
205582	Agricultural Water--Documentation of Scientific Data (one-time burden)	New

ICR Details

OMB Control No: 0910-0739	ICR Reference No: 201301-0910-007
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: 18528
Title: Product Safety Standards--Recordkeeping and Third Party Disclosure Requirements
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 04/23/2013
	Date Received in OIRA: 01/30/2013
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. OMB files this comment in accordance with 5 CFR 1320.11( c ). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The proposed recordkeeping requirements are necessary for covered farms to ensure their own compliance with these aspects of the proposed rule and for FDA to ensure that covered farms are complying with the same aspects of the proposed rule. Therefore, these proposed requirements are necessary for the efficient enforcement of the FD&C Act because they will aid both firms and FDA in ensuring that food is not adulterated, and are necessary to prevent the spread of communicable disease because they will aid both firms and FDA in ensuring that food does not become contaminated with human pathogens.

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Authorizing Statute(s): PL: Pub.L. 111 - 353 105 Name of Law: Food Safety Modernization Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG35	Proposed rulemaking	78 FR 3503	01/16/2013

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 27

IC Title	Form No.	Form Name
Agricultural Water--Documentation of Scientific Data (one-time burden)
Recordkeeping Related to Soil Amendments (one-time burden)
Sprouts--Establishment of Environmental Monitoring Plan (one-time burden)
Sprouts--Establishment of Sampling Plan (one-time burden)
Variances (one-time burden)
Training
Recordkeeping Related to Water--Documentation to Support Alternative to Requirements of 112.44(c)
Documentation of Certificates of Compliance
Recordkeeping Related to Soil Amendments
Recordkeeping Related to Cleaning and Sanitation--Cleaning worker tools/machinery
Testing Requirements for Sprouts--Testing for E.coli and Salmonella
Teating Requirements for Sprouts--Testing for Listeria
Recordkeeping Related to Sprouts--Environmental Monitoring Plan
Recordkeeping Related to Sprouts--Sampling Plan
Recordkeeping Related to Sprouts--Testing for E.coli and Salmonella/Listeria
Recordkeeping Related to Corrective Actions
Review of Records
Recordkeeping Related to Sprouts--Documentation of Treatment
Documentation (one-time burden third party disclosure)
Posting signage
Recordkeeping Related to Agricultural Water--Records of Analytical Test Results
Recordkeeping Related to Agricultural Water--Documentation of Monitoring Water Treatment
Testing Requirements for Agricultural Water--E.coli Testing
Recordkeeping Related to Agricultural Water--Testing for E.coli when water is directly applicated/for handwashing/e.coli in other water uses
Testing Requirements for Agriculture Water--Testing Water Used for Hand Washing
Testing Requirements for Agricultural Water--Testing for E.coli when water is directly applicated/Analytical Testing
Recordkeeping Related to Agricultural Water--Findings of Water System Inspection

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new proposed rule. Section 105 of the Food Safety Modernization Act amends the FD&C Act to create a new section 419 which mandates rulemaking.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 01/30/2013

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